WuXi stock plum­mets, wip­ing near­ly $10B off mar­ket val­ue as US adds it to ‘un­ver­i­fied’ list

As Covid-19 has made it more dif­fi­cult for US reg­u­la­tors to car­ry out rou­tine in­spec­tions, WuXi Bi­o­log­ics has been hit with un­ver­i­fied sta­tus, caus­ing its stock to plum­met, and wipe $9.9 bil­lion off of its mar­ket val­ue be­fore trad­ing of its shares was halt­ed.

WuXi’s stock tum­bled 26% in Hong Kong af­ter the com­pa­ny was added to the US De­part­ment of Com­merce’s un­ver­i­fied list. The com­pa­nies on the list are hit with stricter im­port con­trols. WuXi is list­ed right on page 7 of the re­port, along with an­oth­er 70-plus com­pa­nies based in Chi­na. The list­ing means that it is un­able to re­ceive items sub­ject to the ex­port ad­min­is­tra­tion reg­u­la­tions, and ex­porters on the list must file an Au­to­mat­ed Ex­port Sys­tem record.

This list­ing does not mean that the com­pa­ny has been black­list­ed — an in­for­mal term for a list of com­pa­nies that US in­vestors are barred from own­ing shares in, or mov­ing shares they al­ready have — and the com­pa­ny made sure that was known in a state­ment it re­leased Mon­day.

“We un­der­stand that the rea­son for this ac­tion is be­cause U.S. gov­ern­ment agen­cies have not been able to un­der­take re­quired end-use ver­i­fi­ca­tions in or­der for cer­tain equip­ment to be ex­port­ed from US sup­pli­ers,” it said. “The ‘Un­ver­i­fied List’ is not the US ‘En­ti­ty List’ or ‘Black List’ that are more well known.”

WuXi has been im­port­ing hard­ware con­trollers for biore­ac­tors and hol­low fiber fil­ters that are sub­ject to US ex­port con­trol for the last 10 years and says that it has been in com­pli­ance with reg­u­la­tions ever since. But the De­part­ment of Com­merce’s ver­i­fi­ca­tion process has not been able to take place in the last two years thanks to Covid-19, and that is enough to land on the un­ver­i­fied list.

“This has no im­pact on our busi­ness or on­go­ing ser­vices to glob­al part­ners. There is very min­i­mal im­pact to our im­ports as no such equip­ment is re­quired af­ter fa­cil­i­ty con­struc­tion in Shang­hai and Wuxi,” the state­ment said. “We wel­come in­spec­tion at any time for the clear­ance and re­moval from such list. We are al­so pur­su­ing in­ter­im mea­sures to re­move these sub­sidiaries from the list pri­or to in­spec­tion.”

The stock slide comes as a bit of a re­turn to Earth for the com­pa­ny that had ex­pe­ri­enced such strong suc­cess in re­sponse to the de­mand for Covid-19 vac­cine man­u­fac­tur­ing. A re­port from CPhI in No­vem­ber said that along with Lon­za, Sam­sung and Fu­ji­film Diosynth Biotech­nolo­gies, WuXi would have the largest man­u­fac­tur­ing ca­pac­i­ty in the world by 2025, so long as trends con­tin­ue in the same di­rec­tion.

It al­so opened up a mas­sive ex­pan­sion at its Wuxi, Chi­na head­quar­ters, adding an eighth drug pro­duc­tion fa­cil­i­ty and the ca­pac­i­ty to bring 60 mil­lion vials a year of com­mer­cial drug pro­duc­tion.  The 129,166-square-foot fa­cil­i­ty is called DP2 and has an iso­la­tor fill­ing line for con­tin­u­ous pro­duc­tion, which will elim­i­nate cross-con­t­a­m­i­na­tion.

In to­tal, 33 Chi­nese com­pa­nies have been added to the un­ver­i­fied list. DOC as­sis­tant sec­re­tary for ex­port en­force­ment Matthew Ax­el­rod said in a state­ment that the ver­i­fi­ca­tion process is a core prin­ci­ple for the con­trol sys­tem. The ad­di­tion of those com­pa­nies to the list “will as­sist U.S. ex­porters in con­duct­ing due dili­gence and as­sess­ing trans­ac­tion risk, and sig­nal to the PRC gov­ern­ment the im­por­tance of their co­op­er­a­tion in sched­ul­ing end-use checks.”

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.

The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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